Drug, Healthcare and Patient Safety最新文献

Purpose: The second-generation antipsychotic quetiapine has been associated with misuse and dependency. We aimed to review questions to the Norwegian network of drug information centers concerning this potential drug safety problem.

Methods: We conducted a Boolean search in the database of the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS) combining the indexed categories "quetiapine" and "adverse drug reaction" with the text words "misuse" or "dependency". Question-answer pairs (Q/As) in the full-text, searchable RELIS database were defined as cases. Cases were analyzed for drug safety issues linked to use of quetiapine, including off-label use, polypharmacy and other patient risk factors.

Results: The search resulted in 54 cases. Forty-six cases (85%) were patient-related, and a majority came from physicians working in hospitals. Twenty-nine cases (54%) concerned patients with a history of addiction, 14 cases (26%) had polypharmacy, and off-label use of quetiapine for insomnia was identified in 14 of the cases (26%). Only three of the cases included a specific question about patient dependency of quetiapine, and these cases were all associated with insomnia.

Conclusion: We conclude that our case series from the Norwegian network of drug information centres reflects that quetiapine frequently involves clinical narratives of a history of addiction, polypharmacy or insomnia (off-label use). However, the case series did not reveal new information about the drug's addictive potential.

Introduction: Patient safety is an issue of global concern; however, health-care organizations have lately observed to pay more attention to the importance of establishing a culture of safety. The study aimed to assess the level of patient safety culture and associated factors among health-care providers at the University of Gondar comprehensive specialized hospital, Northwest Ethiopia, 2020.

Methods: A cross-sectional study design supported by the qualitative approach was conducted from March 15 to May 15/2020. A stratified simple sampling technique was used to select 575 study participants. The standardized tool, which measures 12 safety culture dimensions, was used for data collection. Bivariate and multivariable linear regression analyses performed using SPSS version 23. The significance level was obtained at 95% CI and p-value <0.05. For the qualitative part, a semi-structured interview guide with probing was used. Data were analyzed thematically using open code software version 4.02.

Results: The overall level of positive patient safety culture was 45.3% (95% CI: 44.7, 45.9) with a response rate of 92.2%. Factor analysis indicated that female, masters, participation in patient safety program, adverse event report, hospital management encourage reporting event and resource were positively associated with the patient safety culture. Whereas divorced/widowed, midwives, anesthetist, medicine, pediatrics, emergency, outpatient, pharmacy, direct contact with patients, and hospital management blame when medical errors happened were negatively associated. The in-depth interview revealed that teamwork, health-care professionals' attitude toward patient safety and patient involvement as important factors that influence patient safety culture.

Conclusions and recommendations: The overall level of positive patient safety culture was low. All variables except age, training, working hour, and working experience were factors significantly associated with the patient safety culture. Health-care policy-makers and managers should consider patient safety culture a top priority, and also create a blame-free environment that promotes event reporting.

Background: Usage of traditional-herbal medicines (THM) for various illnesses has been increased around the world, so does the adulteration of these products with hazardous compounds. There are limited Malaysian data that have been published on the characteristics trend and adverse events associated with adulterated THM products.

Aim: This study described characteristics of adulterated THM products in Malaysia and aimed to quantify THM products' safety signals of adverse reactions (ARs).

Methods: THM products that were seized by Pharmacy Enforcement Division between 2008 and 2014 were extracted and analysed for 59,440 THM products. Of these, only 6452 THM products with complete information were included in the final analyses. Safety signalling tools were used to measure AR signals from AR reports obtained from the National Pharmaceutical Regulatory Agency Adverse Drug Reaction Database.

Results: More than half of adulterated THM products originated from countries outside of Malaysia, with the majority were from Indonesia. The most common claimed indication of adulterated THM products was for pain and fever relief, while steroids were the most common adulterant. AR signals were generated for cough and cold products for respiratory and thoracic disorders, weight-loss products for cardiac disorders, and women's health products for reproductive and breast disorders.

Conclusion: Health authorities from various fields can work collaboratively by implementing strategic actions that include the use of safety signalling tools to curb the increasing number of adulterated THM products in the Malaysian market.

Background: Post-anesthesia recovery is a continuous process which is considered to be complete after the patient returns to their preoperative physiological state. Although all patients who have had an operation under anesthesia are in a potentially unstable physiological state, most patients recover safely without significant problems due to better and immediate post-anesthesia care. Therefore, this study aimed to assess the staffing and service provision in the post-anesthesia care unit.

Methods: A multicenter, institution-based cross-sectional study was conducted in post-anesthesia care units from November 28 to December 31, 2020. The data were collected using a questionnaire prepared from standards and guidelines of the American Society of Anesthesiologists, the American Association of Nurse Anesthetists, and the Royal College of Anesthetists by direct observation.

Results: Ten hospitals found in Amhara regional state were examined for their staffing of and service provision in their post-anesthesia care units. The total ratio of nurses assigned in post-anesthesia care units to post-anesthesia care unit beds was around 1:3, with a minimum and a maximum ratio of 1:8 and 1:2, respectively. The average number of patients admitted in post-anesthesia care units per week was 98. Eighty percent of the hospitals' post-anesthesia care units had no policy or caregivers for cardiac arrest management.

Conclusions and recommendations: Standards, policies, and guidelines are not well prepared and posted so as to be visible to every caregiver. The majority of the hospitals have staff without special training for the management of possible complications in the post-anesthesia care unit. Generally, hospitals need to ensure standardized patient care in the post-anesthesia care unit for better and safer patient outcomes.

Background: Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)' real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population.

Methods: Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM).

Results: Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups.

Conclusion: Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM's physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM's safety profile.

The care of older patients with cancer is becoming increasingly complex. Common challenges for this population include management of comorbidities, safe transitions of care, and appropriate medication use. In particular, polypharmacy-generally defined as the regular use of five or more medications-and inappropriate medication use can lead to adverse effects and poor outcomes in older adults with cancer, including falls, hospital readmissions, cognitive impairment, poor adherence to essential medications, chemotherapy toxicity, and increased mortality. Managing polypharmacy across different cancer care settings is often challenging. Providers face barriers to safe and successful medication management that may include lack of time, absence of reimbursement, underappreciation of the scale of polypharmacy-related harm, lack of ownership of deprescribing efforts, and poor communication across care settings. Existing literature on managing inappropriate medication use and polypharmacy in older adults with cancer has often focused on ideal state settings in which resources are plentiful and time is purposefully allocated for medication interventions. This paper presents a narrative, rather than a systematic review, of studies published in the past decade that provided detailed information on medication management and polypharmacy across cancer care settings. This review aims to also summarize different healthcare provider roles in taking action against inappropriate medication use and polypharmacy in older adults with cancer.

Introduction: Patients presenting to the emergency department (ED) frequently require procedural sedation and analgesia (PSA) to facilitate procedures, such as joint reduction. Proper documentation of screening demonstrates awareness of the necessity of presedation assessment. It is unknown if introducing emergency physicians (EPs) at the ED improves presedation assessment and documentation. In this study the differences in documentation of ED sedation and success rates for reduction of hip dislocations in the presence versus absence of EPs are described.

Methods: In this retrospective descriptive study, we analyzed data of patients presenting with a dislocated hip post total hip arthroplasty (THA) shortly after the introduction of EPs. The primary outcome measure was the presence of documentation of presedation assessment. Secondary outcomes were documentation of medication, vital signs, and success rate of hip reductions.

Results: In the two-year study period, 133 sedations for hip reductions were performed. Sixty-eight sedations were completed by an EP. The documentation of fasting status, airway screening, analgesia use, and vital signs was documented significantly more often when an EP was present (respectively 64.9%, 80.3%, 37.4%, and 72.7%, all P < 0.001). There was no difference in success rate of hip reductions between the groups.

Conclusion: PSA in the ED is associated with superior documentation of presedation assessment, medication, and vital signs when EPs are involved.

The role of patient adherence in improving the efficacy of any treatment is widely accepted, as well as its impact in optimizing the use of healthcare resources and associated costs. Adherence is particularly affected in chronic conditions, such as rheumatoid arthritis (RA), requiring long-term therapies and a commitment of the patient to manage his/her disease. Methotrexate (MTX) is one of the mainstays of treatment for several immune-mediated inflammatory joint and skin diseases, especially RA. The use of parenteral MTX, particularly when administered as a subcutaneous (SC) injection, has recently raised a great interest to overcome the limitations of oral MTX. For addressing this issue, new optimized self-injection systems have been developed to improve the ease of use of SC MTX. Increasing evidence shows how patients tend to opt for autoinjectors over prefilled syringes or conventional syringes in terms of easiness of use, preference and satisfaction, regardless of whether the treatment is a biologic or MTX. Additionally, positive views and beliefs of patients about treatment may contribute to increasing expectations of effectiveness and treatment adherence. Similarly, the implementation of prefilled pens in clinical practice might be a way to facilitate and simplify the self-injection of SC MTX delivery, optimizing adherence and treatment outcomes as a consequence. This article aimed to review the available literature data on the use of MTX autoinjectors and their impact on treatment adherence and patients' perceptions.

Background: Cytotoxic drugs (CDs) administration and occupational exposure is a worldwide concern. Inappropriate handling may cause toxic residues to infiltrate hospital environments and patient care areas, and can even be traced to patients' homes. Hence, the study sought to assess knowledge and practices on the safe handling of cytotoxic drugs Among Oncology Nurses at Tertiary Teaching Hospitals in Addis Ababa, Ethiopia.

Methods: The researchers conducted a hospital-based cross-sectional study among 77 nurses from April 1-30, 2019. Purposive sampling was used in recruiting the respondents. Structured questionnaires were filled through self-administered interviewing. Data were analyzed using SPSS version 23 software. Multiple linear regression was performed to see the association between dependent variables and independent variables at a p-value of less than 0.05.

Results: Mean score of knowledge and practice of nurses was 7.82±2.22 out of 15 and 22.1±5.50 out of 40 respectively. Nearly 69% of nurses reported the lack of training program on the handling of CDs at their workplaces and the use of Personal Protective Equipment (PPE) remains suboptimal as none used all of PPE. Nurses who had not heard about CDs had an average knowledge score of 0.33 points lower than nurses who had heard about CDs (p ≤ 0.01). Nurses who have scored higher knowledge points had 0.33 points more practice score of safe CD handling than those who had lower knowledge score (p < 0.05) and also married nurses had average safe CDs handling practice score 0.27 points lower than their counterparts (p < 0.05).

Conclusion: Nurses' knowledge and practice of safe handling of cytotoxic drugs are inadequate. Nurses who have scored higher knowledge points and are married were more likely to practice safe CD handling. Provision of proper PPE and training regarding the handling of CDs for Oncology Nurses are recommended and chemotherapy safety protocol and guidelines should be established.

Background: Irrational use of drugs has been one of the major problems around the globe. However, the degree of the problem is higher in developing countries like Ethiopia. The WHO has developed several indicators to evaluate the practices of drug use. This study aimed to assess the overall drug use practices using standard WHO indicators in Lumame Primary Hospital.

Methods: Hospital-based retrospective cross-sectional study was employed to investigate the overall drug use practices at the hospital. Six hundred prescriptions were selected from a total of 19,242 prescriptions by systematic sampling technique over one year from July 1, 2019, to June 30, 2020, in a retrospective review. For the patient care study, 100 patients were selected for collecting the required information. Facility indicators were assessed by checking the availability of STG/formularies and essential drugs. The results were interpreted according to the standard values of WHO.

Results: All 600 sampled prescriptions were 100% standard. Weight, dosage form, and quantity were written in 1.5-13.3% of the prescriptions. Patient address was recorded in 51%, while qualification of prescriber and dispenser were recorded in 71.5% and 56% of the cases, respectively, but all other information were complete in 88.5-100% of the prescriptions. The mean number of drugs per encounter, generic prescribing, prescribing from essential drug list, encounters with antibiotics and injectable drugs were 2.3, 97.9%, 99.8%, 48.8%, and 11.2%, respectively. The average dispensing time was found to be 171.9 seconds. Percentage of actually dispensed drugs, adequacy of labeling, patient knowledge, and patient satisfaction were 95.3%, 22.6%, 83%, and 88%, respectively. About 92% of tracer drugs and all reading materials, except national drug list and facility-level drug formulary, were available in the study period.

Conclusion: Generally, appreciable results were obtained for most of the indicators but improvement in antibiotic prescribing, polypharmacy and labeling practice is recommended.